Flex Pharma Initiates CMT Phase 2 Trial with FLX-787 in US

Flex Pharma announced that, under its open investigational new drug (IND) application, the Company has initiated a Phase 2 randomized, controlled, double-blinded, parallel design trial in the US, referred to as the COMMIT trial. The COMMIT trial will evaluate FLX-787, the Company’s co-activator of TRPA1 and TRPV1, in patients with Charcot-Marie-Tooth, who suffer from painful, debilitating cramps. The Company expects to report topline results from this study in the middle of 2018. The Company initiated a Phase 2 clinical trial in ALS earlier this quarter. The FDA has granted FLX-787 Fast Track designation for the treatment of severe muscle cramps associated with ALS.

“Many of our patients with CMT neuropathy suffer from frequent and severe muscle cramping which can limit their activities of daily living and have a profound impact on their quality of life,” stated CMT clinical trial lead investigator, Dr. Nicholas Johnson, Assistant Professor of Neurology, Pediatrics and Pathology at the University of Utah. “FLX-787 promises to have significant clinical advantages because of its safety profile and the lack of systemic exposure.”

“As one of the very few companies conducting interventional studies in CMT, we are excited to be at the forefront of clinical development for this disease, an orphan indication that is the most common form of inherited neuromuscular disease,” commented Dr. William McVicar, Flex Pharma President and CEO. “These new Phase 2 IND studies, as well as completion of the ongoing exploratory Phase 2 work in Australia, are expected to result in several important data readouts in 2018.”